Skip to main content
OpenTrials
Completed

NCT Number: NCT00904098

Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine

Females 18 years of age or older with at least one year history of menstrual migraine (MM) headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (International Headache Society [IHS] Grade 1) of MM compared with patients' current treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Menstrual Migraine (MM) Headaches Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Stratford, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Had MM headaches occurring between Day -2 and Day +3 of menses
  • Had at least one year history of MM headaches
  • Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)
  • Had regular predictable menstrual periods (28 ± 4 days)

Exclusion criteria

  • Had a history of more than 15 headache days per month
  • As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)
  • Had a history of myocardial infarction, ischemic heart disease (or presented with symptoms or signs compatible with ischemic heart disease), coronary vasospasm (including Prinzmetal's variant angina), other significant underlying cardiovascular disease, or peripheral vascular disease
  • Had significant cerebrovascular disease, including basilar or hemiplegic migraine
  • Had uncontrolled hypertension: systolic blood pressure >180mmHg and diastolic blood pressure >95mmHg
  • Had severe hepatic or renal insufficiency
  • Used an analgesic medication (including both prescription and over-the-counter) for any reason >50% of days per month

Treatment and study plan

frovatriptan

Drug

This study employed a prospective, non-randomized, open-label single-sequence design. The study was conducted in two phases:

  • A Usual Care phase (approximately 1 month in duration) included one menstrual period during which female patients treated all episodes of migraine headaches using their current treatment (referred to as the Baseline phase in the protocol)
  • An Acute Treatment phase (approximately 1 month in duration), following the Usual Care phase, included one menstrual period during which female patients used frovatriptan 2.5 mg to treat all episodes of migraine headache when their headache reached IHS Grade 1. If needed, a second dose of frovatriptan 2.5 mg was administered; however, this second dose could not be administered within 2 hours of the initial dose (i.e., there must have been at least 2 hours between doses of frovatriptan). The total daily dose of frovatriptan was not to exceed 3 tablets over a 24-hour period.

Usual Care

Drug

Current treatment used to treat all migraine headaches

Primary outcomes

  1. Headache pain severity

    Time frame: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)

Secondary outcomes

  1. Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia)

  2. Occurrence and severity of functional impairment during menstrual migraine

  3. Use of rescue medication and additional frovatriptan dose

  4. Patient satisfaction with treatment

  5. Patient preference of current vs. study treatment (end of study only)

  6. Safety as assessed by occurrence of AEs

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment)Of Menstrual Migraine

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 19, 2009
Registry last updated
Feb 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.